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Набор скоро начнётся NCT07570394

BREZTRI REGULATORY POST MARKETING SURVEILLANCE IN KOREA

— Наблюдательное Chronic Obstructive Pulmonary Disease (COPD)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
Кому может быть актуально
Состояния в реестре: Chronic Obstructive Pulmonary Disease (COPD). Базовые параметры: Без ограничений · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Список центров уточняется — проверьте первичный протокол.
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

As part of a post-approval commitment requested by the Ministry of Food and Drug Safety (MFDS), this open-label, single-arm, multicentre, observational Post-Marketing Surveillance (PMS) study aims to characterize the safety profile of Breztri in real-world clinical practice settings, either confirming known safety outcomes or identifying previously unsuspected adverse drug reactions. The study will also evaluate effectiveness of Breztri in real-world clinical practice settings, generating essential clinical evidence from a broader and more diverse Korean patient population representative of daily medical practice.

Подробное описание

This is an open-label, single-arm, multicentre, observational study. Eligible patients who initiate treatment with Breztri according to approved indications will be enrolled after obtaining informed consent. All patients treated (minimum 600 patients required) with Breztri in accordance with the local prescribing information are eligible for enrolment in this study. Initiation or continuation of Breztri prescription and patient enrolment will depend on physicians' medical decisions as per routine clinical practice. Approximately 30 study sites are expected to participate in this study.

As this study will be performed under clinical practice, the investigator may prescribe any other concomitant medications that are necessary for the patient as locally approved.

The total number of visits and the visit time will be determined at the discretion of the investigator based on the patient's condition.

Patients will be observed for up to 24 weeks. Follow-up will begin on the date of the first administration of Breztri (index date). However, if a patient is found to meet any of the exclusion criteria after enrolment, no additional follow-up (including the 30-day safety follow-up) will be conducted.

The primary objective of this study is to assess safety profile for patients receiving Breztri under the approved indication(s) in Korea.

The secondary objective of this study is to assess effectiveness for patients receiving Breztri under the approved indication(s) in Korea.

The exploratory objective of this study is to identify patients' baseline characteristics that might be associated with safety and effectiveness for patients receiving Breztri under the approved indication(s) in Korean patients.

Первичные конечные точки

  • Incidence proportion of Adverse Events (AEs)/Adverse Drug Reactions (ADRs) [Срок оценки: 24 weeks]
  • Incidence proportion of Serious AEs (SAEs)/Serious ADRs (SADRs) [Срок оценки: 24 weeks]
  • Incidence proportion of Unexpected AEs/Unexpected ADRs [Срок оценки: 24 weeks]
  • Incidence proportion of Unexpected SAEs/Unexpected SADRs [Срок оценки: 24 weeks]
Вторичные конечные точки (2)
  • Change from baseline to week 12 and 24 in pre-dose Forced Expiratory Volume in 1 second (FEV₁) [Срок оценки: 12 or 24 weeks]
  • Change from baseline to week 12 and 24 in COPD Assessment Test (CAT) score [Срок оценки: 12 or 24 weeks]

Критерии участия

Критерии включения

  • Patients who have been diagnosed with COPD.
  • Patients who have newly initiated treatment with Breztri according to the approved label in Korea
  • Provision of signed and dated written informed consent by the patient or legally acceptable representative

Критерии исключения

  • Other off-label indications outside of the locally approved prescribing information
  • Pregnant and/or breast feeding
  • Current participation in any interventional trial

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07570394 · D5980R00025

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗